Furosemide Stress Test Predicting Early Graft Function in Kidney Transplantation (FOSTIK)
Primary Purpose
Kidney Function, Kidney Transplant; Complications, Delayed Graft Function
Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Furosemide Injection
Sponsored by
About this trial
This is an interventional diagnostic trial for Kidney Function focused on measuring furosemide stress test, kidney transplantation, urine output, perioperation, delayed graft function
Eligibility Criteria
Inclusion Criteria:
- Deceased donor kidney transplantation at KCMH
- informed consent is accepted
Exclusion Criteria:
- Known allergy to furosemide
- Surgical complication of allograft
- Urgently needed for dialysis (refractory hypervolemia, uremic symptoms, and hyperkalemia)
Sites / Locations
- King Chulalongkorn Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Furosemide
Arm Description
Single dose of furosemide 1.5 mg/kg intravenously will be given to all participants at 3 hours post-reperfusion of kidney allograft. Urine output will be recorded hourly for 6 hours.
Outcomes
Primary Outcome Measures
Urine output
Urine output per hour (milliliters/hour) after furosemide injection
Secondary Outcome Measures
Delayed graft function
Delayed graft function is defined by the necessity of dialysis within the first week after kidney transplantation. (yes/no)
Creatinine reduction ratio
Ratio of serum creatinine at postoperative day 7 and 14 to day-zero creatinine
Full Information
NCT ID
NCT03071536
First Posted
February 20, 2017
Last Updated
November 10, 2022
Sponsor
King Chulalongkorn Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03071536
Brief Title
Furosemide Stress Test Predicting Early Graft Function in Kidney Transplantation
Acronym
FOSTIK
Official Title
Furosemide Stress Test as a Marker of Postoperative Kidney Allograft Function
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2016 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Chulalongkorn Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Furosemide is an old drug that has been used frequently in the postoperative period of kidney transplantation, aiming to achieve adequate urine output. There is no previous study that directly evaluate the urine response to standardized dose of furosemide in the postoperative period. The objective is to measure the urine output after standardized dose of furosemide is delivered, as a biomarker to predict the graft function in perioperative period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Function, Kidney Transplant; Complications, Delayed Graft Function
Keywords
furosemide stress test, kidney transplantation, urine output, perioperation, delayed graft function
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Furosemide
Arm Type
Experimental
Arm Description
Single dose of furosemide 1.5 mg/kg intravenously will be given to all participants at 3 hours post-reperfusion of kidney allograft.
Urine output will be recorded hourly for 6 hours.
Intervention Type
Drug
Intervention Name(s)
Furosemide Injection
Intervention Description
Furosemide 1.5 mg/kg intravenously at 3 hours post-reperfusion of kidney allograft
Primary Outcome Measure Information:
Title
Urine output
Description
Urine output per hour (milliliters/hour) after furosemide injection
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Delayed graft function
Description
Delayed graft function is defined by the necessity of dialysis within the first week after kidney transplantation. (yes/no)
Time Frame
7 days
Title
Creatinine reduction ratio
Description
Ratio of serum creatinine at postoperative day 7 and 14 to day-zero creatinine
Time Frame
At postoperative day 0,7 and 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Deceased donor kidney transplantation at KCMH
informed consent is accepted
Exclusion Criteria:
Known allergy to furosemide
Surgical complication of allograft
Urgently needed for dialysis (refractory hypervolemia, uremic symptoms, and hyperkalemia)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suwasin udomkarnjananun, M.D.
Phone
66899679885
Email
suwasin.u@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
suwasin udomkarnjananun, M.D.
Organizational Affiliation
King Chulalongkorn Memorial Hospital and Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suwasin Udomkarnjananun, M.D.
Phone
66899679885
Email
suwasin.u@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30636249
Citation
Udomkarnjananun S, Townamchai N, Iampenkhae K, Petchlorlian A, Srisawat N, Katavetin P, Sutherasan M, Santingamkun A, Praditpornsilpa K, Eiam-Ong S, Avihingsanon Y. Furosemide Stress Test as a Predicting Biomarker for Delayed Graft Function in Kidney Transplantation. Nephron. 2019;141(4):236-248. doi: 10.1159/000495765. Epub 2019 Jan 11.
Results Reference
derived
Learn more about this trial
Furosemide Stress Test Predicting Early Graft Function in Kidney Transplantation
We'll reach out to this number within 24 hrs